Kornimate/medical-research-clean huggingface dataset:
alt-801 in diabetic and non-diabetic overweight and obese subjects with non-alcoholic fatty liver disease (nafld)

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: the purpose of the study is to assess the safety and tolerability of alt-801 in diabetic and non-diabetic subjects with overweight and obese and non-alcoholic fatty liver disease (nafld).

this is a phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the effects of alt-801 the safety of alt-801and effects on hepatic fat fraction, anthropometric parameters, lipid metabolism, inflammatory markers and fibrosis markers in diabetic and non-diabetic overweight and obese (bmi 28.0-45.0 kg/m2) subjects with nafld.

Eligibility criteria:
inclusion criteria: * written informed consent signed prior to the performance of any study procedures * male or female volunteers, age 18 to 65 years, inclusive * overweight to obese (greater than or equal to bmi 28.0 * magnetic resonance imaging derived proton density fat fraction (mri-pdff) ≥ 10% * if subject has type 2 diabetes mellitus (t2dm), on stable regimen, for at least 3 months prior to screening, of any combination (1) diet and exercise, (2) metformin with absent or mild gastrointestinal symptoms (nausea, vomiting or diarrhea), and/or (3) sodium glucose cotransporter-2 (sglt-2) therapy exclusion criteria: * women who are pregnant or breastfeeding * type 1 dm and/or insulin-dependent t2dm, or uncontrolled t2dm defined as hba1c ≥ 9.5% * history of pancreatitis or hypersensitivity reaction to glp-1 analogues

Keywords: obese overweight
a study of the pharmacokinetics of black cohosh

Conditions: Hot Flashes

Summary: black cohosh is a natural supplement that has been used to treat and prevent menopausal symptoms. remifemin is a standardized form of black cohosh. the purpose of this study is to determine the levels of components of black cohosh obtained in the blood of healthy women taking remifemin.

as per brief summary

Eligibility criteria:
inclusion criteria: * no prior diagnosis of cancer other than non-melanoma skin cancer or carcinoma in-situ of the cervix * no current prescription medication use * negative urine pregnancy test or greater than age 50 with no menses for at least one year or documented status post hysterectomy * competent to understand and sign informed consent

Keywords: black cohosh pharmacokinetics alternative therapies natural product
performance evaluation of the biological diagnosis of hit

Conditions: Heparin-induced Thrombocytopenia (HIT)

Summary: heparin-induced thrombocytopenia (hit) is a severe complication of heparin therapy with a non-negligible incidence (estimated at 2.6% of unfractionated heparin treatments and 0.2% of low molecular weight heparin treatments). it is generally secondary to the appearance of igg antibodies directed against the platelet factor 4 (pf4) - heparin complex. these antibodies, once bound to this complex, are likely to activate platelets: the thrombotic risk generated can be potentially fatal.


Eligibility criteria:
inclusion criteria : * adult patient (≥ 18 years of age) * hospitalized at hus between 01/01/2009 and 31/12/2019 * specimen sent to the hus hematology laboratory for biological diagnosis of hit between 01/01/2009 and 31/12/2019 * data collected by the crpv and analyzed by the hit multidisciplinary group in order to reach a consensus decision on the presence or absence of hit * patient does not object to the reuse of his medical data for scientific research purposes. exclusion criteria: * patient for whom no test has been performed at the hus hematology laboratory * patient for whom no data has been collected by the crpv * patient for whom the hit group could not confirm or deny the presence of hit

Keywords: heparin-induced thrombocytopenia hit heparin therapy heparin treatments molecular weight heparin igg antibodies platelet factor 4 (pf4) heparin complex thrombotic risk
interval training and plasma volume variation

Conditions: Hematologic Tests

Summary: the goal of this clinical trial is to to compare the effects of high (hiiwt) versus moderate-intensity interval walking training (miiwt) on body composition, plasma volume variations (pvv), hematological parameters, muscle damage and aerobic capacity in overweight/obese postmenopausal women. the main question it aims to answer is:does hiiwt and miiwt improve kidney function markers in this population? researchers will compare hiiwt to miiwt and to non-training intervention(designed to control group) to see if the training program at different intensities work to improve kidney function markers. participants in hiiwt group will: perform a 8-week hiiwt program, three sessions per week (5 repetitions of 6-min-walking-test (6mwt) at 90-110% of 6mwtdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). participants in miiwt group will: perform a 8-week miiwt program, three sessions per week (5 repetitions of 6-min-walking-test (6mwt) at 60-80% of 6mwtdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). participants in control group will : not perform any physical training and maintain their usual daily activities.

in obese postmenopausal women, hematological disturbances, reduced plasma volume, and elevated muscle damage biomarkers are associated with impaired oxygen delivery, reduced aerobic capacity, and increased risks of cardiovascular disease, sarcopenia, and functional decline. while responses to exercise are well documented in young healthy individuals, evidence in this high-risk population remains scarce. the purpose is to compare the effects of high (hiiwt) versus moderate-intensity interval walking training (miiwt) on body composition, plasma volume variations (pvv), hematological parameters, muscle damage and aerobic capacity in overweight/obese postmenopausal women.thirty-two overweight/obese postmenopausal women were randomly assigned to hiiwt (n = 11), miiwt (n = 11), or control (con, n = 10) groups. hiiwt and miiwt groups performed intermittent walking at 90-110% and 60-80% of the 6-min-walking-test distance, respectively, 3 times/week for 8 weeks (60 min/session). body composition, hematological and muscle damage markers, and 6 min walk test (6mwt) were assessed pre- and post-intervention. pvv was calculated after eight weeks under third conditions (hiiwt, miiwt and con).

Eligibility criteria:
inclusion criteria: * age range of 45-59 years. * postmenopausal women (cessation of menses for at least 12 consecutive months). * body mass index (bmi) ≥ 25 kg/m2. * body weight remained constant (±2 kg) during the past 3 months. * stable eating habits and physical activity for at least 3 months. * sedentary lifestyle (exercise less than 1h/week). exclusion criteria: * medical contraindications to physical activity, diagnosed metabolic, hormonal, orthopedic, or cardiovascular conditions. * current use of hormone replacement therapy or any prescribed medication.

Keywords: hematocrit plasma volume variation interval walking training lactate dehydrogenase obesity
the efficacy and safety of tislelizumab combined with anlotinib and s1 plus oxaliplatin as neoadjuvant therapy for the locally advanced adenocarcinoma of esophagogastric junction

Conditions: Immunotherapy Gastroesophageal Junction

Summary: to evaluate the efficacy and safety of tislelizumab combined with antilotinib and sox regimen for neoadjuvant treatment of locally advanced esophagogastric junction cancer


Eligibility criteria:
inclusion criteria: * female and male patient ≥ 18 and ≤ 75 years. * histologically confirmed, medically operable, resectable adenocarcinoma of the gastroesophageal junction (aeg, siewert ii-iii)，ut3, ut4a, ut4b any n category, m0, or any t n+ m0 patient * ecog≤1 * no previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed. * exclusion of distant metastases by ct or mri of abdomen, pelvis, and thorax, bone scan or mri (if bone metastases are suspected due to clinical signs). * preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells. * the expected survival time is more than 6 months. * women of childbearing age shall be those who agree to use contraception (such as intrauterine devices, contraceptives or condoms) during the study and for 6 months after the end of the study; those who have a negative serum or urine pregnancy test within 7 days before study enrollment and must be non-lactating; and men who agree to use contraception during the study and for 6 months after the end of the study. * hematological, hepatic and renal function parameters adequate to allow surgical procedure and chemotherapy * patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures exclusion criteria: * diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ). * significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. if fecal occult blood was positive at baseline, reexamination could be performed, if it was still positive after reexamination, gastroscopy was required. * prior treatment: anti-pd-1, anti-pd-l1, or anti-pd-l2 drugs or drugs that target another stimulating or co-inhibiting t-cell receptor (e.g., ctla-4, ox-40, cd137). * a history of immunodeficiency, including hiv testing positive. * is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing. * patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally. * her2 positive is known. * patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.
postoperative analgesia in laparoscopic gynecological surgeries

Conditions: Postoperative Pain

Summary: the aim of this study is to compare intraperitoneal instillation of magnesium sulfate versus sodium bicarbonate as an adjuvant to lidocaine 1% , on reducing postoperative pain in laparoscopic gynecological surgeries.

patients undergoing laparoscopic surgery experience postoperative pain especially in the abdomen, lower back, and shoulders, relieving postoperative pain, especially with certain types of analgesic agents, may reduce postoperative morbidity and mortality. it is also important to prevent adverse events such as myocardial infarction, cardiac arrhythmia, ileus, and poor wound healing and pulmonary complications. there is evidence that the main source of pain after laparoscopic surgeries is the peritoneum . due to co2 insufflation constitutes the commonest means of creating the pneumoperitoneum. co2pneumoperitoneum is known to cause systemic acidosis. which is responsible for damaging of the mesothelial lining of the peritoneum and consequent peritoneal irritation . moreover, the phrenic nerve could be damaged by the acidic environment the use of local anesthetics has been advocated as a method for reducing postoperative pain local anesthetic intraperitoneal administration has shown good effects on reducing postoperative pain in laparoscopic cholecystectomy and gynecological surgeries . intraperitoneal sodium bicarbonate instillation may neutralize effect of the acid milieu on peritoneal cavity and the phrenic nerve damage which consecutively will lead to a reduction of postoperative pain. magnesium sulfate, a non-competitive nmda antagonist, has been proven in animal and human being models to have antinociceptive properties. the antinociceptive effect of magnesium sulfate relieves chronic pain and it can also decrease the duration and intensity of postoperative pain.

Eligibility criteria:
inclusion criteria: * age 18:60years * patients undergoing laparoscopic gynecological surgeries, * asa 1\&2 exclusion criteria: * patient dissatisfaction for participating in the study * opioid use within 24 hr before the study * allergy to the drugs used in the study and alcohol use * chronic pain syndrome. * neurological disease. * steroid treatment * conversion of laparoscopic surgery to open surgery * use a drain

Keywords: laparoscopic gynecological surgeries
soft lens study: biomedics 1 day extra sphere and clariti 1 day sphere

Conditions: Myopia

Summary: the aim of this study is to evaluate and compare the performance of two soft contact lenses.

the aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing myopic soft lens wearers.

Eligibility criteria:
inclusion criteria: 1. are at least 18 years of age and have full legal capacity to volunteer; 2. have understood and signed an information consent letter; 3. are willing and able to maintain the appointment schedule; 4. are an adapted soft contact lens wearer; 5. have a vertex-corrected contact lens prescription of -1.00ds to -6.00ds (inclusive) in each eye; 6. have a refraction with a cylinder component of no more than -1.00dc in each eye; 7. can be fitted with and achieve a distance visual acuity of +0.10 logmar or better in each eye with the study contact lenses. exclusion criteria: 1. are participating in any concurrent clinical or research study; 2. have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use; 3. have a systemic condition that would contraindicate contact lens use; 4. are using any systemic or topical medications that would contraindicate contact lens use; 5. have known sensitivity to the diagnostic fluorescein sodium to be used in the study; 6. are an employee of the centre for ocular research \& education directly involved in the study (i.e. on the delegation log).
hypersensitivity to phosphodiesterase 5 inhibition in post-traumatic headache

Conditions: Post-Traumatic Headache

Summary: to investigate whether sildenafil (phosphodiesterase 5 inhibitor) induces migraine-like headache in people with persistent post-traumatic headache (pth) attributed to mild traumatic brain injury (mtbi).


Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age upon entry into screening * history of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the international classification of headache disorders, 3rd edition (ichd-3) * ≥ 4 monthly headache days on average across the 3 months prior to screening * provision of informed consent prior to initiation of any study-specific activities/procedures exclusion criteria: * \> 1 mild traumatic injury to the head * history of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache) * history of moderate or severe injury to the head * history of whiplash injury * history of craniotomy * history or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion * the subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior * female subjects of childbearing potential with a positive pregnancy test during any study visit * cardiovascular disease of any kind, including cerebrovascular diseases * hypertension (systolic blood pressure of ≥150 mmhg and/or diastolic blood pressure of ≥100 mmhg) prior to the start of infusion on the experimental day * hypotension (systolic blood pressure of ≤90 mmhg and/or diastolic blood pressure of ≤50 mmhg) * initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion * intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start * baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache) * baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
behavioral intervention for children with attention deficit hyperactivity disorder(adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: adhd children have executive function (ef) impairments,so we randomize the children to the training or a waitlist to improve ef ,adding contingent reinforcement to ascertain whether ef deficits are amenable to the training in children with adhd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of child adhd * full-scale intelligence quotient (fsiq) ≥70 * stable on medication for adhd children at least 3 months exclusion criteria: * individuals with major neurological disorders * a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders

Keywords: executive function training child
pilot study to determine feasibility of benign and malignant skin lesion detection.

Conditions: Skin Lesions

Summary: in this study a fluorescent contrast dye is applied to a suspicious skin lesion. images are acquired and processed. the information is used to develop a prediction model for the presence of malignant transformation in the skin.

images acquired in the study are used for the development of a software analysis program.

Eligibility criteria:
inclusion criteria: * over the age of 18 * individual is scheduled for a skin biopsy in toto * the lesion is pigmented or non pigmented * lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis. * the lesion is accessible to the imaging device exclusion criteria: * the patient has sensitive skin and easily breaks out in rash * the lesion is within 1 cm of the eye * the lesion is on mucosal surfaces (e.g., lips, genitals) * pregnant females * taking medications that pigments the skin
safety study of keyhole gallbladder surgery with removal of gallbladder via the stomach rather than through the skin

Conditions: Gallstones

Summary: the benefits of laparoscopic ("minimally invasive" or "keyhole") surgery for gallbladder removal (cholecystectomy) over open surgical procedures in terms of significant reductions in pain, scarring and recovery time are well accepted. in a conventional laparoscopic cholecystectomy however, the excised gallbladder still has to be extracted through the abdominal wall skin via a laparoscopic port site using an incision of 10mm or greater. despite being much smaller than that required for open surgery, this incision is painful, leaves a scar and can result in a port site hernia to follow requiring further surgery to repair it. recent attempts to further reduce the invasiveness of the surgical procedure have suggested performing the operation via an endoscope passed through the mouth and through an incision in the stomach wall - so called natural orifice translumenal endoscopic surgery (notes). unlike a skin incision, an incision in the wall of the stomach (gastrotomy) should give no pain, visible scar or herniation risk yet still allow access to the peritoneal cavity for surgical procedures such as cholecystectomy. against this, it has the potential risks of contamination and leakage of gastric contents into the peritoneal cavity. whilst the limitations of present technology make it very difficult to perform an entire cholecystectomy through the stomach wall in patients, endoscopic methods for closing a gastrotomy are available that are approved for use in patients (ce marked) and it is hypothesised that removing the excised gallbladder through the stomach in this way would avoid the problems of extracting it through the abdominal wall described above. data are required to determine whether the extraction of the gallbladder via a gastrotomy rather than through the skin is safe, producing smaller scars and a better cosmetic result. a secondary endpoint would be to assess possible reductions in pain and recovery from this less invasive approach.


Eligibility criteria:
inclusion criteria: * fit patients, avoiding extremes of age, with uncomplicated gallstone disease requiring elective laparoscopic cholecystectomy. exclusion criteria: * direct healthcare team deny permission to approach patient for trial. * patient request / preference. * age (\ 65 yrs old). * co-morbidity (asa level 3 or above). * bmi \> 32. * complicated gallstone disease (eg bile duct stones/ercp/pancreatitis). * gallstones ≥ 18 mm size (too large to recover via oesophagus). * pregnancy. * previous gastric or upper abdominal surgery (alterations in gastric anatomy or adhesions preventing safe gastrotomy). * emergency procedure. * planned other operation during cholecystectomy. * inability to consent or psychiatric or addiction problems relevant to surgery.

Keywords: natural orifice transluminal endoscopic surgery (notes) transgastric surgery surgical procedures, minimally invasive
full-thickness-gastroplication for the treatment of gastroesophageal reflux disease gerd

Conditions: Gastroesophageal Reflux Disease

Summary: this is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and impedance-ph-monitoring after full-thickness-gastroplication.


Eligibility criteria:
inclusion criteria: * persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related demeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes \>73. exclusion criteria: * any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (american society of anesthesiologists (asa) scores iii and iv) and pregnancy.